A Safety and Efficacy Study of a Nutraceutical in Aging Males With Thinning Hair

NCT06854575 | Terminated

• 1 other identifier: NW-MSS-01
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 3

Brief Summary

A study to assess the safety and efficacy of a dietary supplement when used over the course of 9 months by men with self-perceived hair thinning.

Conditions

Hair Thinning

Outcome Measures

Primary Outcomes (1)

• Hair Growth Global Improvement Scale rating at 6 months

  Blinded Investigator mean Hair Growth Global Improvement Scale rating at 6 months for treatment group as compared to placebo

  6 months

Secondary Outcomes (1)

• Investigator Hair Quality Global Improvement Scale at 6 month

  6 months

Study Arms (2)

Active

EXPERIMENTAL

Dietary Supplement

Dietary Supplement: Dietary Supplement

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Dietary Supplement DIETARY_SUPPLEMENT

Oral dietary supplement

Active

Placebo OTHER

Placebo pill

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: The study population will comprise only of adult men.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, 40 to 65 years of age.
• In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
• Having Fitzpatrick skin type I-IV.
• Having overall hair thinning (diffuse thinning of the top of the crown or at temples and/or widening part or receding hair line) confirmed by the study dermatologist at baseline (grade III, IIIa, III vertex, IV, or IVa on the Hamilton-Norwood scale).
• With self-perceived thinning hair on the scalp.
• Willing to participate in the Hair Pull Test, in which a trained practitioner will grasp a 4-6mm bundle of hair near the scalp and firmly tug the hair.
• Having a regular mild, non-medicated shampoo and conditioner (if used) and willing to bring the product(s) in to the first clinic visit for documentation and to continue using the product(s) for the duration of the study.
• Willing to continue using regularly used hair styling products (mousse, hairspray) if used, and not start using any new hair products for the duration of the study.
• Willing to maintain the same hair length, hairstyle, and coloring practices for the duration of the study. Those with color-treated hair must have the color treatment performed at the same time interval prior to each visit.
• Willing to maintain current diet (eg, amount, type, and frequency of food and drink consumed).
• Willing to not wear hats, scarves, or other head coverings on your head during each study visit.
• Willing to refrain from using any topical hair products or treatments on the hair that could affect hair properties (eg, heat treatments, hair relaxers, permanent wave, medicated shampoo, etc) for the duration of the study except for the test material and regular shampoo and conditioner (if used) and styling products.
• Willing to refrain from hair extensions, tight braids, or hair weaves for the duration of the study.
• Willing to refrain from taking any vitamins, minerals, or herbal supplements with claims related to hair growth or benefits during the study, and to not start taking any new vitamins, minerals, or supplements of any kind during the study.
• Willing to avoid using prescription or over-the-counter (OTC) products designed to or claiming to significantly impact hair loss and/or hair growth for the duration of the study.

You may not qualify if:

• Having a pregnant partner or a partner that is planning to become pregnant during the study.
• Having a known allergy to any ingredients in the test products.
• Having a history of skin cancer within the past 5 years.
• Having hair extensions, hair weave, tight braids, crew cut, or very short hair (less than 1.5 inches in length).
• Having started any new vitamin, mineral, or herbal supplement within 30 days prior to baseline.
• Smokers with usage \>20 cigarettes/day.
• Who have been diagnosed with hair loss disorders such as alopecia areata, scarring alopecia, traction alopecia, chemical alopecia, trichotillomania or trichorrhexis nodosa, or suffering from moderate to severe hair loss disorder (grade V-VII on the Hamilton-Norwood scale) confirmed by the investigator.
• Having hair loss due to disease, injury, or medical therapy.
• Who have a history of hair transplants or surgical procedures to the head that may have impacted skin anatomy (eg, flaps, grafts, plugs).
• Who have very brittle or severely damaged hair from causes including chemical treatments and excessive tension on the hair (from, eg, tight ponytails or hair extensions).
• Having a history of persistent burning, itching, or stinging of the scalp.
• Having clinically active bacterial, fungal, or viral skin infections or those who have a history of skin infections, according to subject self-report.
• Who are currently using, planning to use, or have used laser/light therapy (such as HairMax, iRestore), microneedling or scalp micropigmentation, or used any prescription or over-the-counter (OTC) products designed to or claiming to significantly impact hair loss and/or hair growth (eg, minoxidil, Rogaine, finasteride, Propecia, Nioxin shampoo, or oral supplements (such as Biotin \>500mcg or Nutrafol)) within 6 months of study start.
• Having not used any prescription or over-the-counter (OTC) products designed to or claiming to significantly impact hair loss and/or hair growth (eg, minoxidil, Rogaine, finasteride, Propecia, Nioxin shampoo, or oral supplements (such as Biotin \>500mcg or Nutrafol) for at least 6 months prior to baseline, and willing to avoid all such products for the duration of the study.
• Who are currently using, planning to use, or have used anabolic-androgenic steroids (testosterones) or anti-androgen medication (such as spironolactone, flutamide, cyproterone acetate, cimetidine) other than oral contraceptives; platelet-rich plasma (PRP) injections; or tamoxifen within 3 months of study start. (Men currently undergoing hormone/testosterone replacement therapy \[TRT\] can be eligible for the study if they have maintained a stable dose for at least 6 months prior to enrollment and stay on the same dose throughout the study.)

Sponsors & Collaborators

• Nutraceutical Wellness Inc.: lead

Study Sites (3)

SGS Phoenix Research Center

Phoenix, Arizona, 85029, United States

Location

SGS Elizabeth Research Center

Elizabeth, New Jersey, 07208, United States

Location

SGS Dallas Research Center

Richardson, Texas, 75081, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: March 10, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)